FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Senior Biostatistician
Clinical Outcomes Solutions. Provide statistical support to clinical studies .
About the role
Key responsibilities & impact- Provide statistical support to clinical studies
- Participate in study protocol development, study design discussions, and sample size calculations
- Review CRFs and data review guidelines
- Develop statistical analysis plans, including analysis dataset and TLG specifications
- Perform statistical analyses and interpret statistical results
- Prepare clinical study reports, including integrated summaries for submissions
- Present and explain methodology and consequences of decisions
- Understand and follow FDA regulations affecting clinical trial data reporting, including good clinical practice and electronic submission guidelines
- Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
- Participate in developing CRFs, edit check specifications, and data validation plans
- Review or author data transfer specifications for external vendor data
- Collaborate with internal and external functions, including CROs, software vendors, and clinical development partners, to meet project timelines and goals
- Review or author SOPs and work instructions related to statistical programming practices
Requirements
What you’ll need- Master’s degree in statistics or a related discipline
- Ph.D. strongly desired
- 5+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry
- Experience working for a CRO is strongly desired
- Experience with oncology is a bonus
- Experience in sample size calculation, protocol concept development, protocol development, SAP, and preparing clinical study reports including integrated summaries for submissions
- Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers
- Knowledge of R programming is a plus
- Solid understanding and implementation of CDISC requirements for regulatory submissions
- Adept in ADaM specifications generation and QC of datasets
- Ability to build strong external and internal relationships and motivate a regional or global team
- Effective communication skills, including explaining methodology and consequences of decisions in lay terms
Benefits
Comp & perks- Consistent training, development and support
- Significant professional growth opportunities
- Autonomy and ownership while working embedded with a pharmaceutical client